MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG SOMATOM DEFINITION AS; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	08098027
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to siemens that an incident occurred while operating a somatom definition as ct system.According to the customer the ct examination was performed due to hematuria.During a whole-body scan, after the patient had already been positioned in the gantry, the operator in the control room pressed the movement button on the control box in order to move the patient handling system (phs).While the phs with the patient was moving back from the tabletop, the patient¿s elbow dangled off the tabletop and was fractured.The injury was discovered only after completion of the table movement as the patient had suffered a stroke and was unable to speak.
Additional Manufacturer Narrative
According to available information no acute stroke patient was involved in the reported event.The examination was not performed to treat a stroke but was scheduled because of hematuria.The patient required surgical treatment for the fracture.At the time of reporting, the patient had already left the hospital.However, no negative health consequences caused by the system itself were reported.Siemens healthineers completed a safety and technical assessment.The investigation confirmed that the system functioned as specified and no malfunction or design issue was identified.The root cause of the event was attributed to customer related issue, as the patient¿s body parts were not fully positioned on the patient table during table movement.The following warnings are clearly stated in the instructions for use: somatom definition as ¿ instructions for use print no.C2 029.620.16.03.02 page 172ff: caution ¿ lowering the patient table! body parts can get caught.Make sure that the patient¿s body parts are above the patient table.Make sure that neither body parts of anybody nor any objects are below the patient table.Page 171: stop keys with the stop keys, table movements can be interrupted in an emergency, and radiation can be switched off.Based on the available information, no systematic, general, or design issue was identified.

• Brand Name: SOMATOM DEFINITION AS
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1 -or-; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 -or-; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: marion mints ; 40 liberty blvd.; malvern, PA 19355 ; 4843231632
• MDR Report Key: 25279849
• Report Number: 3004977335-2026-00085
• Device Sequence Number: 21224384
• Product Code: JAK
• UDI-Device Identifier: 04056869003665
• UDI-Public: (01)04056869003665
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K230421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 08098027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown